NATIONAL DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY COUNCIL

January 25, 2013

National Institutes of Health Bethesda, MD

MINUTES

The National Deafness and Other Communication Disorders Advisory Council convened on January 25, 2013 in Building 31, Conference Room 6, National Institutes of Health (NIH), Bethesda, MD. Dr. James F. Battey, Jr., Director, National Institute on Deafness and Other Communication Disorders (NIDCD), served as Chairperson. In accordance with Public Law 92-463, the meeting was:

Closed: January 25, 2013: 8:30 a.m. to 9:35 a.m. for review of individual grant applications; and Open: January 25, 2013: 9:50 a.m. to 12:10 p.m., for the review and discussion of program development needs and policy. Council members in Attendance1:

Ms. Brenda Battat Dr. Charlotte Mistretta Dr. Gerald Berke Dr. John Niparko Dr. William Brownell Dr. Joseph Perkell Mr. Richard Ellenson Dr. James Schwob Dr. Karen Friderici Dr. Robert Shannon Ms. Joan Kaye Dr. Helen Tager-Flusberg Dr. Paul Manis Dr. Bevan Yueh

Council members absent:

Dr. Lauren Bakaletz Dr. Tommie Robinson Ms. Tisha Kehn

Ex-Officio Members Participating:

Dr. Kyle Dennis for Dr. Lucille Beck

Ex-Officio Members Not Participating:

Dr. Rickie Davis Dr. Michael E. Hoffer The complete Council roster is found in Appendix 1.

1For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective

institutions or (b) in which a real or apparent conflict of interest might occur. This procedure applies only to individual discussion of an application and not to

"en bloc" actions.

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NIDCD employees present during portions of the meeting:

Ms. Nuria AbdulSabur Dr. Chuan-Ming Li Dr. Kathy Bainbridge Dr. Christine Livingston Mr. Chris Carlsen Dr. Castilla McNamara Ms. May Chiu Dr. Roger Miller Dr. Laura Cole Mr. Robert Miranda-Acevedo Dr. Judith Cooper Ms. Kristen Mullsteff Dr. Janet Cyr Mr. Christopher Myers Ms. Sherry Dabney Mr. Edward Myrbeck Ms. Susan Dambrauskas Mr. Eric Nunn Ms. Laura Damiano Dr. Christopher Platt Ms. Lesley DeRenzo Mr. Chris Rosado Mr. Hoai Doan Mr. Steve Schecter Dr. Amy Donahue Dr. Lana Shekim Dr. Nancy Freeman Dr. Daniel Sklare Ms. Maria Garcia Ms. Nanette Stephenson Dr. Andrew Griffith Dr. Melissa Stick Mr. Howard Hoffman Dr. Susan Sullivan Ms. Debbie Holmes Dr. Bracie Watson Dr. Gordon Hughes Ms. Ginger Webb Ms. Nichelle Johnson Mr. Timothy Wheeles Mr. Vivek Kamath Mr. Baldwin Wong Dr. Andrea Kelley Mr. Chad Wysong Dr. Lisa Kennedy Dr. Jean Tiong-Koehler Ms. Robin Latham Dr. Shiguang Yang Ms. Mimi Lee

Other federal employees present during portions of the meeting:

Dr. Cate Bennett, CSR Dr. Rene Etcheberrigaray, CSR Dr. Seymour Garte, CSR Dr. Paek Lee, CSR Dr. Lynn Luethke, CSR Ms. Juanita Marnes, OSP Dr. Christine Melchior, CSR Dr. Richard Nakamura, CSR Dr. Weijia Ni, CSR Dr. Biao Tian, CSR Ms. Esther Weiss, OHR Members of the public present during open portions of the meeting: Mr. Andy Bopp, Hearing Industries Association Dr. Leigh Hochberg, Brown University Ms. Melinda Moyer, ICF International (NIDCD Clearinghouse Contractor) Ms. Kate Thomas, American Academy of Audiology

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CLOSED SESSION

I. Call to Order and Opening Remarks ........................................... Dr. James F. Battey, Jr.

The meeting was called to order by Dr. Battey, Director, NIDCD, who expressed appreciation to the entire Council for their service and advice. Dr. Tager-Flusberg was welcomed to the group as a new council member with the promise of a more formal introduction in the Open Session.

II. Council Procedures ............................................................................. Dr. Craig A. Jordan

Procedural Matters

Dr. Jordan discussed important procedural matters, including requirements imposed by the Government in the Sunshine Act and the Federal Advisory Committee Act. The necessity of members to avoid conflict of appearance thereof was stressed, as was the need to maintain confidentiality concerning the proceedings and materials related to the closed portion of the meeting. Dr. Jordan announced that the Council meeting would be closed for consideration of grant applications during the morning session, but would be open to the public at approximately 10:30 a.m.

III. Council Consideration of Pending Applications

A. Research Project Grant Awards

1. Consideration of Applications: On the Council’s agenda was a total of 104 investigator-initiated research grant applications; 93 applications had primary assignment to NIDCD, in the amount of $30.6 million first-year direct costs. It is anticipated that, of the applications competing at this Council, NIDCD will be able to award grants to R01 applications scoring up through the 15th percentile.

B. Special Programs Actions

1. National Research Service Award Institutional Training Grants (T32): The Council recommended support of 6 applications.

2. Ruth L. Kirschstein National Research Service Award Short-Term Institutional Research Training Grants (T35): The council Recommended support of one application.

3. NIH Pathway to Independence (PI) Award (K99): The Council recommended support of three applications.

4. NIH Small Grants (R03): The Council recommended support of seven applications.

5. NIH Support for Conferences and Scientific Meetings (R13): The Council recommended

support of one application and partial support of two applications with dual assignment.

6. NIH Academic Research Enhancement Awards (AREA) (R15): The Council recommended support of one application.

7. NIH Exploratory/Development Research Grant Award (R21): The Council recommended

support of five applications.

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8. NIDCD Research Core Center Grants (P30): The Council recommended support of one application.

9. NIDCD Clinical Research Center Grants (P50): The Council recommended support of one application.

10. NIH Small Business Technology Transfer Awards (STTR): The Council recommended

support of one Phase II (R42) application.

11. NIH Small Business Innovation Research Awards (SBIR): The Council recommended support for one Phase I (R43) application.

12. NIH Small Business Innovation Research Awards (SBIR): The Council recommended support for one Phase II (R44) application.

13. RFA-DC-12-004 Improving Access to Hearing Healthcare (SBIR) [R43/R44]: The Council

recommended support for two Phase II (R44) applications.

OPEN SESSION

IV. Opening Remarks ............................................................................................... Dr. Battey

Dr. Battey welcomed additional staff and visitors to the open session of the meeting.

Recognition of New Member

Dr. Battey welcomed the following new member to the Advisory Council:

• Dr. Helen Tager-Flusberg is Professor at the Department of Anatomy and Neurobiology and Professor at the Department of Pediatrics at Boston University. She received her doctoral degree in Experimental Psychology/Psychology and Social Relations from Harvard University. Her research interests include addressing essential characteristics of the cognitive/psychological phenotype that define different neurodevelopmental disorders with special interest in autism, specific language impairment (SLI) and Williams Syndrome. The goal of her research is to define the disorders by understanding the nature of the deficits and spared capacities that are unique and specific to particular syndromes. Approaches include identifying cognitive markers that will support research on underlying genetics and better defining the neuropathology especially for autism and SLI, which are both complex genetic disorders. Dr. Tager-Flusberg is a member of several professional organizations including, President, the International Society for Autism Research and the Society for Neuroscience. She is on the editorial board of several scientific journals. She is widely published and served on numerous peer review panels.

Consideration of Minutes of the Meeting of September 7, 2012

Dr. Battey called the members’ attention to the minutes of the September 7, 2012 meeting of the Advisory Council. The minutes were approved as written.

Confirmation of Dates for Future Council Meetings

Dates for the Council meetings through September 2014 have been established. A list of these meetings was distributed to the Council members and posted on the web site prior to this meeting.

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The next meeting of the Council is scheduled for Friday, May 31, 2013, in Building 31, Conference Room 6 on the NIH campus, Bethesda, Maryland. V. Report of the Director, NIDCD ........................................................................... Dr. Battey

Budget Update Dr. Battey began his presentation by sharing the current status of the budget indicating first that we are operating under a continuing resolution (CR) through March 27, 2013. He also pointed out the uncertainty contributed by two other issues, The American Taxpayer Relief Act and the Federal Debt Limit on the NIH budget for FY 2013. He indicated that the Administration is confident the Congress will be able to replace sequester with a balanced approach to the long-term spending issues and the budget deficit. In the meantime, NIH will not further ramp down spending in anticipation of a sequester; but continue to operate cautiously, pursuant to the law as well as general and NIH-specific policies for operating under a CR until a final FY 2013 funding is determined. This includes continuing to fund non-competitive grants in FY 2013 at 90% of the approved level as has been NIH practice. He also pointed out that there has been no Congressional action yet on the FY 2013 budget for NIH. As a consequence, there is a great deal of uncertainty about what the eventual budget level will be and it is possible that NIH will continue FY 2013 without an appropriation, operating under a CR until a final FY 2013 funding is determined. In recognition of this high level of uncertainty, NIDCD is continuing with a conservative fiscal plan for FY 2013. Dr. Battey then provided details about the NIDCD budget plan. Once other components of the NIDCD budget are considered there would be $299.4 million available for research project grants. From this total, $10.7 million is reserved for Small Business Research grants, $900 thousand for administrative supplements, $226.8 million for commitments to noncompeting grants, $650 thousand for carryover commitments from last year, and $12.7 million for program requirements. An additional $1.4 million was applied from end of year FY 2012 funds. Twenty percent of the remaining $49 million is designated for High Program Priority (HPP). Consequently, there is $39.2 million available for the initial pay line across the year’s three Council meetings. This should allow funding of applications up through the 15th percentile. The $9.8 million for HPP applications will be available to support additional applications. [A copy of the slides Dr. Battey used for this budget presentation is included in Appendix 2.]

VI. Scientific Presentation ............................................................................. Dr. Leigh Hochberg Dr. Battey introduced Dr. Leigh Hochberg, Associate Professor, Brown University. Dr. Hochberg accepted our invitation to discuss his research in a presentation entitled “Neural Interfaces for Restoring Communication.” For people with cervical spinal cord injury, pontine stroke, neuromuscular disease including amyotrophic lateral sclerosis, and other neurologic illnesses, currently available assistive and rehabilitation technologies are inadequate. In severe brainstem stroke and advanced ALS, patients may suddenly or progressively enter a locked-in state of being awake and alert but unable to move or communicate. Through clinical translation based on decades of fundamental neuroscience research, intracortically-based “brain-computer interfaces” are poised to revolutionize our ability to restore lost communication. Over the past decade, neurotechnologies to record the individual and simultaneous activities (action potentials, multi-unit activity, and local field potentials) of dozens to hundreds of cortical neurons have yielded new understandings of cortical function in movement, vision, cognition, and memory. This preclinical research, generally performed with healthy, neurologically intact non-human primates, has demonstrated that direct neural control of virtual and physical devices can be achieved. Recently, this exciting research has been translated into initial

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pilot clinical trials (IDE) of an intracortically-based neural interface system (BrainGate), seeking to determine the feasibility of persons with tetraplegia controlling a computer cursor or other devices simply by imagining movement of their own hand. A variety of methods for decoding brain signals are now being tested with the hope of not only restoring communication, but also providing a control signal for the reanimation of paralyzed limbs.

VII. Report of the Director, Division of Extramural Activities ..................................... Dr. Jordan Endorsement of Council Operating Procedures Dr. Jordan called Council’s attention to a copy of the Council Operating Procedures which had been provided to members prior to the meeting. The Council Operating Procedures state those actions which Council empowers staff to take without specific prior Council approval. It is the NIDCD’s practice to review the Council Operating Procedures annually at the January meeting of Council. He pointed out the minor changes to the document this year to address the addition of NIH’s new practice of Special Council Review of research applications from PDs/PIs with more than $1.0 million direct costs. Dr. Jordan reviewed the document and it was endorsed unanimously for the current year; a copy is included in these minutes as Appendix 3. Inclusion of Women and Minorities in Research Populations On a biennial basis, the advisory councils of the Institutes comprising the National Institutes of Health (NIH) are asked to review the procedures used by their respective institutes to implement the 1994 NIH guidelines for the inclusion of women and minorities in clinical research. The current report provides inclusion data for FY2011 and FY2012 and information about NIDCD staff efforts and responsibilities. The previous review was performed in 2011. In preparing for this meeting, Council was asked to review NIDCD implementation of the 1994 NIH Guidelines, and to certify NIDCD’s compliance with them. The report entitled “2013 Biennial Advisory Council Report Certifying Compliance with Inclusion Guidelines, NIDCD” and appendices to this report, containing background material, summary data tables, etc., were provided to Council members and posted on the Council website to allow time for their review prior to the meeting. Dr. Jordan led the discussion of these guidelines, after which a vote was taken; the Advisory Council unanimously confirmed NIDCD compliance.

VIII. Report of the Director, Division of Scientific Programs ........................... Dr. Judith Cooper Dr. Cooper introduced Dr. Daniel Sklare, NIDCD program director and Research Training Officer who, along with colleague Dr. Janet Cyr, recently convened a workshop titled “Moving the NIDCD Research Training Program Forward in Fiscally Constrained Times”. The full report of the workshop may be found on NIDCD’s public website at: http://www.nidcd.nih.gov/research/training/Pages/Moving-NIDCD-Research-Training-Forward-2012.aspx. As an introduction to the workshop report, Dr. Sklare reminded everyone that the goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) Program is to prepare promising individuals to launch successful independent research careers. He pointed out that ongoing NIH and NIDCD budgetary constraints and changes in the scientific research education/training and employment landscapes have motivated the Institute to re-examine a few priority questions focusing on the respective roles of individual vs. institutional training programs for training individuals across the scientific disciplines serving the NIDCD’s research mission. In August 2012, nine accomplished, forward-thinking scientists, research mentors and administrators were convened to consider the following questions: 1) What is the optimal balance for the NIDCD Research Training Program across the individual fellowship (F30/F31 and F32) and institutional training grant (T32) NRSA support vehicles?, and, 2) What are the respective utilities of the individual F31 predoctoral and F32 postdoctoral fellowship award mechanisms across the scientific disciplines serving the NIDCD Research Mission? The Workshop participants were focused on considering these questions in relation to the research training of non-clinician scientists, rather than on the unique challenges of nurturing clinician-investigators. As background information to

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launch Workshop discussions of the principal questions, Drs. Sklare and Cyr presented a historical view of the NIDCD NRSA Program and data on outcomes of Institute-supported fellows and trainees. The Workshop participants concluded that both the T32 Programs and the individual Fellowship Programs are important vehicles for furthering the research training mission of the Institute. However, F32 fellows are more likely to remain in the scientific mission areas of the Institute than F31 fellows, and, the former are a strong investment for nurturing budding independent scientists to become competitive for R01 funding. The following actions were recommended by the Workshop participants: 1) Institute Scientific staff should outreach to the scientific community to encourage the submission of F32 applications; 2) Second-level NIDCD review and funding recommendations should consider F32 applications separately from F30 and F31 applications, with an emphasis upon augmenting the F32 portfolio; 3) T32 Program Directors should be encouraged to limit their postdoctoral trainee appointments to 1-2 years in appropriate cases, in favor of nurturing follow-up F32, K99/R00 or R03 applications from promising candidates; and, 4) In the event that fiscal conditions necessitate substantive reductions to the Institute’s NRSA Budget, the number of T32-based postdoctoral traineeship positions should be decreased in favor of augmenting both the numbers of F32 awards and of predoctoral T32 traineeship positions.

IX. “The Future of Peer Review” ............................................................... Dr. Richard Nakamura Dr. Nakamura began by revisiting the NIH’s Enhancing Peer Review initiative that began in 2007 and the changes this brought about at CSR. He also provided statistics about the large number of grant applications (85,000 annually) that are processed by CSR on behalf of all the ICs at NIH, of which CSR conducts the initial peer review on the majority (58,000). Such a large review effort involves 230 Scientific Review Officers, who convened 1,400 review meetings and utilized 16,000 review consultants. Dr. Nakamura covered a broad range of ‘lessons learned’ from NIH’s efforts to improve Study Section alignment, fund the most promising research earlier, increase the percentage of New Investigator (NI) and Early Stage Investigator (ESI) awards, advancing additional review platforms; recruiting the best reviewers, increasing the peer review focus on Impact and Significance, saving reviewers time, and NIH’s new scoring system. He provided some data on the impact of NIH’s policies on NI/ESI applications with a notable upturn in percentage of awards since FY2007. Dr. Nakamura also presented information on the progress in decreasing the time from application submission to posting of review critiques, reduced approximately 2 months between 2005 and 2009. He also discussed CSR’s efforts to develop/utilize more electronic review formats, provide tangible rewards to reviewers, and to expand the pool of potential peer reviewers. One effort to increase the peer review pool is the CSR’s Early Career Reviewer (ECR) program that will enrich the existing pool of NIH reviewers by including scientists from less research-intensive institutions as well as those from traditionally research- intensive institutions. Dr. Nakamura closed with goals he has for CSR’s future including; developing better tools for applicants/reviewers/referral staff, increasing diversity and decreasing disparity in grant awards, and developing a science of peer review to inform and continually improve CSR’s effort.

X. Adjournment

The meeting was adjourned at 12:10 p.m. on January 25, 2013.

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APPENDICES

APPENDIX 1 NDCD Advisory Council Roster ................................................................... 10 APPENDIX 2 NIDCD Director’s Report Slides ................................................................... 12 APPENDIX 3 NIDCD Council Operating Procedures ........................................................ 17

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Appendix 1 Roster

National Deafness and Other Communication Disorders Advisory Council (Terms end on 5/31 of the designated year)

Chairperson James F. Battey, Jr. M.D., Ph.D., Director

National Institute on Deafness and Other Communication Disorders Bethesda, MD 20892

BAKALETZ, Lauren O., Ph.D. 2014 Professor Departments of Pediatrics and Otolaryngology College of Medicine Ohio State University Columbus, OH 43205 BATTAT, Brenda, M.S., MCSP 2013 Executive Director Hearing Loss Association of America (HLAA) Bethesda, MD 20814 BERKE, Gerald S., M.D. 2014 Chair, Department of Head and Neck Surgery Center for Health Sciences School of Medicine University of California at Los Angeles Los Angeles, CA 90095 BROWNELL, William, Ph.D. 2013 Jake and Nina Kamin Chair Bobby R. Alford Department of Otolaryngology – Head & Neck Surgery Baylor College of Medicine Houston, TX 77030 ELLENSON, Richard, M.B.A. 2013 President Ellenson Interaction New York, NY 10128 FRIDERICI, Karen H., Ph.D. 2013 Professor Department of Microbiology and Molecular Genetics Michigan State University East Lansing, MI 48824 KAYE, Joan 2016 Executive Director Sophie’s Soundcheck New York, NY 10128

KEHN, Tisha A. 2015 Executive Director Association for Chemoreception Sciences Minneapolis, MN 55406 MANIS, Paul B., Ph.D. 2015 Thomas J. Dark Distinguished Research Professor Department of Otolaryngology/Head and Neck Surgery University of North Carolina Chapel Hill Chapel Hill, NC 27599 MISTRETTA, Charlotte M., Ph.D. 2015 William R. Mann Professor Department of Biologic and Materials Sciences Associate Dean for Research and Ph.D. Training School of Dentistry University of Michigan Ann Arbor, MI 48109 NIPARKO, John K., M.D. 2013 George T. Nager Professor Department of Otolaryngology Head and Neck Surgery School of Medicine Johns Hopkins University Baltimore, MD 21287 PERKELL, Joseph S., Ph.D., D.M.D. 2016 Research Affiliate Research Laboratory of Electronics Massachusetts Institute of Technology Cambridge, MA 02446 ROBINSON, Jr., Tommie L., Ph.D. 2016 Director, Scottish Rite Center for Childhood Language Disorders Children's Hearing and Speech Center Children's National Medical Center Washington, DC 20009

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SCHWOB, James E., Ph.D., M.D. 2015 Bates Professor and Chair of Anatomy and Cellular Biology Tufts University School of Medicine Boston, MA 02111 SHANNON, Robert V., Ph.D. 2015 Director, Division of Communication and Auditory Neuroscience Head, Auditory Implant Research Laboratory House Research Institute Los Angeles, CA 90057

TAGER-FLUSBERG, Helen, Ph.D. 2016 Professor Department of Psychology Boston University Boston, MA 02215 YUEH, Bevan, M.D., M.P.H. 2014 Professor and Chair Department of Otolaryngology Head and Neck Surgery University of Minnesota Minneapolis, MN 55455

Ex Officio

BECK, Lucille B., Ph.D. Director Audiology and Speech Pathology Service Department of Veterans Affairs Washington, DC 20422 DAVIS, Rickie, Ph.D. Team Leader Hearing Loss Prevention Team Division of Applied Research and Technology National Institute for Occupational Safety And Health (NIOSH) Cincinnati, OH 45226 SEBELIUS, Kathleen Secretary Department of Health and Human Services Washington, DC 20201

Executive Secretary JORDAN, Craig A., Ph.D. Director, Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Bethesda, MD 20892

COLLINS, Francis S., Ph.D., M.D. Director National Institutes of Health Bethesda, MD 20892 HOFFER, Michael E., M.D. Co-Director Department of Defense Spatial Orientation Center Department of Otolaryngology Naval Medical Center San Diego, CA 92134

Appendix 2

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Appendix 3

NDCD Advisory Council Operating Procedures

(As endorsed by Council on January 25, 2013)

All scored research/training grant applications are taken to the National Deafness and Other Communication Disorders Advisory Council (NDCDAC) for second level review prior to possible funding actions. Specific situations are raised for Council consideration during each meeting. This includes:

1. Applications nominated for High Program Priority consideration,

2. Applications exceeding $500K (DC) that are recommended for support,

3. Applications from Foreign Institutions recommended for support,

4. Applications from PD/PIs with $1M (DC) active research NIH awards (Special Council Review),

5. Letters of Appeal,

6. Applications with issues raised by initial peer review regarding Human Subjects protection/inclusion or Animal Welfare.

The Institute staff may take the following actions on active grants without Council review. All actions shall be documented and presented to the Council for its information at the first appropriate opportunity.

1. Approval of New Principal Investigator or Program Director

Give approval of a new principal investigator or program director to continue an active grant at the grantee institution.

2. Transfer of Award to a New Institution

Make research grant awards equal to the remaining committed support for continuing work under the same principal investigator when that principal investigator moves from one domestic institution to another. This provision will not be automatic, however. Staff may approve less than the remaining committed support and will in all cases carefully document the file with the rationale for the action.

3. Awards for Orderly Termination

Make appropriate awards for orderly termination of competing continuation applications which were not recommended for further consideration, or which received a score too low for payment; this procedure is to be used only in those rare cases where sudden termination of the grant would cause a serious loss of scientific material or impose a hardship to already employed personnel. In such cases, (1) the grant usually should be for a period not to exceed twelve months; (2) careful review should be given to any unobligated balances and needs for salaries and consumable supplies; (3) usually no funds would be provided for additional equipment or travel; and (4) in the case of training grants, support would be provided for those trainees already in the program.

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4. Awards for Interim Period Due to a Deferral

Make awards in an appropriate amount and for an appropriate interim period of time when a recommendation of deferral on a competing continuation application results in a loss of continuity of the active research or training program. Careful review should be given to the needs for personnel and consumable supplies; however, usually no funds would be provided for equipment or travel.

5. Supplemental Support to Existing Research and Training Awards

Provide additional support up to $100,000 in direct costs per year to carry out the scientific, administrative and fiscal intent of the research or training award. The additional support may be necessary to: a) make NIH-wide diversity and re-entry supplement awards; b) provide administrative increases; c) cover unanticipated costs; or d) ensure effective operation of the recommended program. Increases greater than $100,000 will be presented to the NDCD Advisory Council for approval before an award is made.

Institute staff may take the following actions without subsequent reporting to the Council.

1. Continuation of Grant in Temporary Absence of Principal Investigator or Program Director.

Give approval for continuation of grants in the temporary absence of the principal investigator or program director. Give approval for temporary/interim principal investigator or program director.

2. Extension of Project Period Dates

Take necessary action on extensions of project period end dates without additional funds.